Time to major cardiovascular event (MACE; defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke) evaluated during the treatment phase (up to date of last dose of study drug in study A3051123) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Incidence of each of the following events will be assessed up to date of last dose of study drug plus 30 days • MACE; • MACE + (defined as any MACE or a new onset or worsening peripheral vascular disease (PVD) requiring intervention, [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Incidence of each of the following events will be assessed until end of study: • MACE; • MACE + (defined as any MACE or a new onset or worsening peripheral vascular disease (PVD) requiring intervention, a need for coronary [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders.

Official Title ICMJE

A Phase 4, Non-treatment Follow-up For Cardiac Assessments Following Use Of Smoking Cessation Treatments In Subjects With And Without A History Of Psychiatric Disorders

Brief Summary

Non-treatment extension to study A3051123, aimed at collecting data on cardiovascular safety for all participants in the A3051123 trial for an additional 28 weeks, allowing for a total of 52 weeks of cardiovascular safety data collection.

Detailed Description

This study is an extension protocol for study A3051123. No treatment is provided during this study. This study is to monitor for cardiovascular events 28 weeks after completion of A3051123. This study is an extension protocol for study A3051123. No treatment is provided during this study. This study is to monitor for cardiovascular events 28 weeks after completion of A3051123.

Study Type ICMJE

Interventional

Study Phase

Phase 4

Study Design ICMJE

Intervention Model: Single Group Assignment

Condition ICMJE

Smoking Cessation

Intervention ICMJE

Drug: placebo

All dosing to have taken place per study A3051123

Drug: varenicline tartrate

All dosing to have taken place per study A3051123

Other Name: Chantix; Champix

Drug: bupropion hydrochloride

All dosing to have taken place per study A3051123

Other Name: Zyban

Drug: Nicotine Replacement Therapy Patch

All dosing to have taken place per study A3051123

Other Name: NRT

Study Arm (s)

Experimental: placebo

Intervention: Drug: placebo

Experimental: varenicline

Intervention: Drug: varenicline tartrate

Experimental: bupropion

Intervention: Drug: bupropion hydrochloride

Experimental: Nicotine Replacement Therapy Patch

Intervention: Drug: Nicotine Replacement Therapy Patch

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Recruiting

Estimated Enrollment ICMJE

6800

Estimated Completion Date

July 2015

Estimated Primary Completion Date

July 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Subjects will be eligible if they were randomized to study A3051123.

Exclusion Criteria:

Participation in study A3051123 ceased (ie, withdrew consent, lost to follow-up, etc) prior to final visit of study A3051123.